TRIGEN 71755036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010500076), received between Oct 22, 2020 and Nov 4, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K032722, K210980); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2020Migration; Migration

  IT WAS REPORTED THAT, AFTER IMPLANTATION OF A HUMERAL NAIL IMPLANTATION HAD BEEN PERFORMED ON (B)(6) 2020, THE IMPLANT'S PROXIMAL SCREW MOBILISED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2020 FOR THE REPOSITIONING OF THE SCREW. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10785123 ↗
• MalfunctionOct 22, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THERE WAS A MISLABELING ISSUE WITH THE 5 X 36 SELFTAP CAN SCREW TITANIUM. THE CHART STICK LABEL WAS FROM SIZE 5X36 WHEN PACKAGING WAS 5X35 MM. IT CANNOT BE KNOWN AT THE MOMENT WHAT SIZE WAS ACTUALLY IN THE BOX, AS THE SCREW WAS USED IN THE PATIENT ANYWAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10719270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032722, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail